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Three years after it was submitted to the lower house of parliament, the deputies of the State Duma adopted the bill on industrial pharmacies in the second and third readings. If approved by the Federation Council and signed by the President, it will enter into force on September 1, 2023. This document should revive the practice of manufacturing medicines in pharmacies, which was practically destroyed after 2010. Professional associations greeted the bill rather with relief, although they have some complaints about it. How industrial pharmacies will help provide people with the necessary drugs, Izvestia figured it out.

What is the purpose of the bill

Bill allows pharmacy and veterinary pharmacy organizations that have a license for pharmaceutical activities to use medicines in the manufacture of medicines instead of pharmaceutical substances. Also excluded from the law is a ban on the manufacture of drugs registered in the Russian Federation.

Such a document was needed due to the fact that in 2010 61-FZ “On the circulation of medicines” was adopted, which banned the use of finished dosage forms in pharmacy production, changing the dosage of the finished medicine. The explanatory note states that this rule then led to “a significant reduction in the range and number of manufactured dosage forms and the massive closure of industrial pharmacies” in all regions of the country. Production in pharmacies has been possible since 2010 only with the help of pharmaceutical substances, but their assortment does not satisfy the needs of pharmacy production.

— The main obstacle is that there are few substances in the registry that can be sold for sale in pharmacies, – Alexey Martynov, a member of the General Council of Delovaya Rossiya and the board of directors of JSC BARS Group, explained to Izvestia. — The more such substances there are, the larger the range of drugs that can be produced in pharmacy conditions will be. Another problem associated with the sale of substances is that it is necessary to change the packaging so that they are not supplied in packages of 25 kg, but in packages that are convenient and necessary for pharmacy production, up to 100 grams.

Photo: RIA Novosti / Alexander Kryazhev

Earlier, as stated in the explanatory note, in industrial pharmacies, for example, prescriptions were used, including finished dosage forms in the form of ointments, gels, emulsions, essential oils; tinctures, extracts, medicinal plant materials, and so on were used to make potions and decoctions.

The current bill should solve these problems by returning to pharmacies their taken away rights. However, the document is being adopted for a long time: it was approved in the first reading back in 2021, then it was seriously finalized together with the Ministry of Health and the Ministry of Industry and Trade. After signing, the bill will not work immediately either – only from September 2023, because the regulatory framework will be adjusted jointly with the regulators.

How did pharmacies react to the bill?

Nelli Ignatieva, executive director of the Russian Association of Pharmacy Chains, told Izvestia that RAAS supports the bill, as it is an opportunity for a wider operation of industrial pharmacies, which are still available in the country, but in a small number.

“However, this bill is only one of the tools, but not yet a systematic approach to increase the number of such pharmacies.”she says.


Photo: RIA Novosti / Alexei Sukhorukov

Executive Director of AAU SoyuzPharma, Vice President of NP Opora Rossii Maria Litvinova also expressed support for the bill and noted that SoyuzPharma is satisfied with almost all the provisions in the document, except for one important aspect: individual entrepreneurs have been banned from working as industrial pharmacies.

“At the same time, 16 individual entrepreneurs in the country have licenses for manufacturing pharmaceutical activities,” she told Izvestia. — It’s not much, but the very fact of the restriction is very sad. Moreover, everyone is talking about the problem of providing drug care in hard-to-reach regions, but no one manages to solve it. And in hard-to-reach regions, as a rule, just individual entrepreneurs work.

She emphasizes that we are not talking about the fact that the PIs are engaged in the full production cycle, but they could do some small work – for example, divide the drugs to get the children the right dosage.

Litvinova, by the way, generally points to some discrimination against individual entrepreneurs in the development of the pharmaceutical industry: first they were not allowed to become participants in the experiment of remote sale of non-drugs, then they were limited to the ability to keep one retail pharmacy point, now they are forbidden to engage in production activities in pharmacies.


Photo: TASS/Dmitry Rogulin

Speaking about the other provisions of the bill, Litvinova notes that the document, of course, expands the possibilities and resolves issues that were previously unresolvable.

“We still had production pharmacies before that,” she says. – As a rule, these are production departments that existed on the basis of state pharmacies, but there are also those that were opened by entrepreneurs. However, there remained an insignificant number of such pharmacies.

Who can help industrial pharmacies

Yan Vlasov, co-chairman of the All-Russian Union of Patients, notes that earlier, production was an integral part of pharmacies. This type of activity is several hundred years old, it actually disappeared in the 1990s, when the concept of pharmacies and the rules for their work changed, he says.

– At the same time, industrial pharmacies solved problems with providing drugs to a number of patients, – Vlasov told Izvestia. – Those who did not need high-tech drugs for the treatment of chronic conditions.


Photo: TASS/Dmitry Rogulin

Olga Shuppo, scientific director of the network of clinics for immunorehabilitation and preventive medicine Grand Clinic, says that the implementation of the bill will spur the development of a personalized approach, to which the healthcare system is now trying to turn around.

“Hormonal, vitamin and other drugs are often needed by patients in individual dosages,” she emphasizes. – Personalized dosages carry minimal side effect for patients. The opening of production pharmacies is a huge step forward towards creating the personalized medicine of the future.

Alexey Martynov also notes that pharmacy production can optimize and personalize the approach to treating patients, and in some cases reduce the shortage of medicines.

– Patients will be sure that they buy exactly the dose that the doctor prescribed for them, and that they will not have unused drugs lying aroundhe says. — In addition, auxiliary substances, solvents, which can cause side undesirable effects, are not used in pharmaceutical production, which is also very important.

The Ministry of Health told Izvestia that the manufacture of medicines in pharmacy organizations will make it possible to meet the need for vital indications of patients in individual dosages of medicines, including ultra-low dosages in pediatric practice.


Photo: TASS/Dmitry Rogulin

Also, in the future, industrial pharmacies will help improve drug provision for patients, including those with orphan diseases, the Ministry of Health added.

What drugs are produced in pharmacies

First Deputy Chairman of the State Duma Committee on Health Leonid Ogul declaredwhat The law is designed to revive the production of pharmaceuticals in pharmacies in small dosages, which are prescribed by a doctor for a specific patient.

— And it’s not just lotions, creams, suppositories and emulsions. This includes off-label drugs, that is, with a minimum dosage, which are needed, for example, for children with low body weight, Leonid Ogul explained.


Photo: RIA Novosti / Alexei Sukhorukov

Yan Vlasov points out that the main products of industrial pharmacies are herbal preparations, which are made from mineral and biological raw materials. Alexey Martynov notes that Now there are a number of pharmacies that produce eye drops, ointments, gels and powders, but in general, the list of drugs that can be prepared in pharmacies is practically unlimited.

– They also produce traditional tablets, capsules, vials with injectable sterile drugsMartynov explained. — Also, medicines are made that are convenient for use in children – lollipops, sweets. In general, children’s dosage forms, for example, to reduce fever: syrup with ibuprofen, antipyretic suppositories, preparations for children with chronic diseases, diabetes or individual intolerance.

According to him, Traditionally, pharmacies produce drugs for the treatment of dermatological diseases, eye diseases, but there are cardiological prescriptions, neurological drugs.

Olga Shuppo says that with the revival of industrial pharmacies, the market for inexpensive but quite effective medicines, ointments, creams and other external agents will be restored.

— These are cheap but popular medicines that have their own consumer and are used in doctors’ prescriptions, she says. – Similar foreign drugs, registered and licensed, cost patients more often than not.


Photo: TASS/Dmitry Rogulin

Maria Litvinova points out that this is also important for the release of drugs in the correct dosages, calculated for a particular patient.

“For example, there is a pill prescribed for a child, but there is no pediatric form of the drug,” she explains. How is it divided? In a domestic way in the kitchen, by eye. This is considered acceptable, although in reality it must take place in a pharmacy that has a license to carry out production activities.

Besides, she says, the bill will help patients with orphan diseases: a number of drugs can be reproduced in such pharmacies. Aleksey Martynov explains that drugs for the treatment of orphan diseases are often needed only in small quantities, and such small-scale production can reduce the cost of treatment.

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